Fourth Covid-19 Vaccine Approved: Austria Expects 2.5 Million Doses

The European Commission granted conditional approval to the Covid-19 vaccine developed by Janssen Pharmaceutica NV, a company within the pharmaceutical division of the Johnson & Johnson group. It is the fourth COVID-19 vaccine approved in the EU.

This authorisation follows a positive scientific recommendation based on a thorough assessment of the safety, effectiveness and quality of the vaccine by the European Medicines Agency (EMA) and is endorsed by the Member States.

European Commission President Ursula von der Leyen stated:

"Janssen's vaccine is the fourth approved vaccine in the EU portfolio and will help us accelerate the vaccination campaign in the second quarter of 2021. It requires only a single dose and brings us another step closer to our shared goal of vaccinating 70% of the adult population by the end of the summer."

EU Health Commissioner Stella Kyriakides added:

"Our portfolio now includes four safe and effective Covid-19 vaccines, and we are doing everything we can to ensure these vaccines reach citizens in Europe and beyond as quickly as possible. A vaccine to be administered once is likely to significantly accelerate the pace of the campaign. With the entry of Janssen's vaccine into the market, we now have access to a total of up to 1.8 billion doses of licensed vaccines from different technology platforms. This is critical for supplying sufficient vaccines to Europe and our international partners. We continue to make every effort to support vaccine manufacturers and ensure they deliver the contracted doses."

Janssen's vaccine is administered in a single dose to adults 18 years of age and older to prevent Covid-19 infection.

It is based on an adenovirus, a harmless virus that introduces the "blueprint" of the virus that causes Covid-19.

This allows the body's own cells to produce the protein unique to the Covid-19 virus.

The human immune system recognizes that this protein is foreign to the body and responds by building natural defenses against infection by Covid-19. The adenovirus in the vaccine cannot replicate and does not cause disease.

Based on the favorable opinion of the EMA, the Commission reviewed all the elements underlying this authorization and consulted the Member States before granting the conditional authorization.

The Commission approved the contract with Janssen on October 8, 2020, and once the conditional marketing authorization is granted, Janssen can begin supplying 200 million doses of its single-dose vaccine to the EU starting in the second quarter of 2021.

Under the contract, Member States have the option to purchase an additional 200 million doses.

They are in addition to the 600 million doses of BioNTech-Pfizer's vaccine, the 460 million doses of Moderna's vaccine and the 400 million doses of AstraZeneca's vaccine.

Austria's Health Ministry sees "tailwind" for the domestic vaccination campaign. The department that the approval was "good news for the EU and for Austria."

"With the fourth vaccine now approved in the EU, our vaccination strategy can be implemented step by step as planned and thus the vaccination campaign can continue to gain momentum," a representative said.

"We currently anticipate availability of approximately 2.5 million doses from Johnson & Johnson by the end of the year at the latest."

The first shipments are expected in the second quarter, the Austrian Health Ministry explained.